Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 32
- Latest Decision
- 2021-06-23
Clearances · page 15 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211045 | Synthetic Vinyl Examination Gloves | Jiangsu Huayuan Medical Technology Co., Ltd. | LYZ | Class I | 2021-06-23 |
| K210258 | NovoFine | Novo Nordisk, Inc. | FMI | Class II | 2021-06-23 |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | Shen Wei USA, Inc. | LZA | Class I | 2021-06-21 |
| K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | 2021-06-21 |
| K210375 | Powder Free Blue Nitrile Examination Glove | Duramitt Sdn Bhd | LZA | Class I | 2021-06-21 |
| K210430 | Intravascular Extension Set | Baxter Healthcare Corporation | FPA | Class II | 2021-06-18 |
| K202964 | iBed Wireless with iBed Mobile | Stryker Corporation | FNL | Class II | 2021-06-18 |
| K202440 | Infrared Thermometer | Shenzhen Sonida Digital Technology Co., Ltd. | FLL | Class II | 2021-06-17 |
| K211310 | AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) | Megine Industries Sdn Bhd | LZA | Class I | 2021-06-16 |
| K211336 | Disposable Vinyl Examination Glove | Inner Mongolia Cureguard Medical Materials Co., Ltd. | LYZ | Class I | 2021-06-16 |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ansell Healthcare Products, LLC | LZA | Class I | 2021-06-13 |
| K203215 | Radius T wearable thermometer | Masimo Corporation | FLL | Class II | 2021-06-11 |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | FRA | Class II | 2021-06-11 |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | BRZ | Class II | 2021-06-10 |
| K210522 | Disposable Vinyl Examination Gloves | Shandong Shengshixincheng Medical Science & Technology Co., | LYZ | Class I | 2021-06-10 |
| K210014 | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) | Guandong Genial Technology Co., Limited | FLL | Class II | 2021-06-04 |
| K211028 | Nitrile Patient Examination Gloves | Huayuan Medical Technology(Shangqiu) Co., Ltd. | LZA | Class I | 2021-06-04 |
| K200891 | BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson and Company | FOZ | Class II | 2021-06-02 |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | LBI | Class II | 2021-05-28 |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | FQH | Class II | 2021-05-28 |
| DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | QOI | Class II | 2021-05-27 |
| K210520 | Disposable Synthetic Examination Gloves | Shandong Shengshixincheng Medical Science & Technology Co., | LYZ | Class I | 2021-05-26 |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | FLL | Class II | 2021-05-20 |
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | JOJ | Class II | 2021-05-19 |
| K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | FRG | Class II | 2021-05-19 |
| K201576 | Disposable Latex Powder Free Examination Gloves (Non-sterile) | Pt. Universal Gloves | LYY | Class I | 2021-05-19 |
| K210217 | Needleless Connector | Jiangsu Caina Medical Co.,Ltd | FPA | Class II | 2021-05-17 |
| K210460 | NitriTec Vinyl Glove Powder Free Blue | Zhonghong Pulin Medical Products Co., Ltd. | LYZ | Class I | 2021-05-17 |
| K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock | Set Medikal Sanayi VE Ticaret Anonim Sirketi | FMF | Class II | 2021-05-14 |
| K210774 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Shandong Jieshi Medical Products Co., Ltd. | LYZ | Class I | 2021-05-14 |
| K210799 | Powder Free Vinyl Patient Examination Gloves | Yunnan Huazhiyuan Medical Technology Co., Ltd. | LYZ | Class I | 2021-05-14 |
| K210780 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Shandong Shangwei Medical Products Co., Ltd. | LYZ | Class I | 2021-05-14 |
| K210369 | Powder Free Nitrile Examination Glove | Pastel Glove Sdn Bhd | LZA | Class I | 2021-05-13 |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | MED | Class II | 2021-05-12 |
| K201504 | Single-use medical poly (vinyl chloride) examination glove | Anhui Bytech Medical Supplies Co., Ltd. | LYZ | Class I | 2021-05-10 |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | Central Medicare Sdn Bhd | LZA | Class I | 2021-05-07 |
| K203572 | Karl Storz Radel Sterilization Trays | Karl Storz Endoscopy America, Inc. | KCT | Class II | 2021-05-07 |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | 2021-05-07 |
| K210755 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) | Meditech Gloves Sdn Bhd | LZA | Class I | 2021-05-07 |
| K201697 | Umbilical Vessels Catheter | Haolang Medical USA Corporation | FOS | Class II | 2021-05-06 |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | KPE | Class II | 2021-05-06 |
| K200893 | ProntoPump Sterile Tube Set | Ipax, Inc. | LHI | Class II | 2021-05-04 |
| K203454 | Infrared Thermometer | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FLL | Class II | 2021-04-29 |
| K210944 | Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) | Harbour Health, LLC | LZA | Class I | 2021-04-29 |
| K203436 | Disposable Nitrile Examination Gloves | Shandong Zhushi Pharmaceutical Group Co., Ltd. | LZA | Class I | 2021-04-28 |
| K203512 | Powder Free Blue Nitrile Examination Glove | Vip Glove Sdn Bhd | LZA | Class I | 2021-04-26 |
| K203264 | MicroDose Injector | Medone Surgical, Inc. | FMF | Class II | 2021-04-26 |
| K202462 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corporation | FRG | Class II | 2021-04-23 |
| K210065 | Verifine Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2021-04-22 |
| K210145 | Nitrile Glove Powder Free Blue | Changzhou Universal Medical Equipment Co., Ltd. | LZA | Class I | 2021-04-21 |
| K203805 | Disposable Nitrile Examination Gloves | Jiangsu Yanfang Medical Technology Co., Ltd. | LZA | Class I | 2021-04-20 |
| K202419 | BIOTECH Nitrile Examination Gloves | Tk Hitech Technology Co., Ltd. | LZA | Class I | 2021-04-16 |
| K203170 | Infrared Thermometer Models: DT-8806S, DT-8807S | Shenzhen Everbest Machinery Industry Co., Ltd. | FLL | Class II | 2021-04-16 |
| K210276 | Disposable Nitrile Gloves | Fujian Ercon Medical Management Co., Ltd. | LZA | Class I | 2021-04-16 |
| K210629 | SecurAcath | Interrad Medical, Inc. | OKC | Class II | 2021-04-12 |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | PTI | Class II | 2021-04-07 |
| K210106 | Nitrile Examination Gloves | Zhenjiang Huayang Latex Products Co., Ltd. | LZA | Class I | 2021-04-07 |
| K201879 | Digital Thermometer Model T103, T104 | Bioland Technology, Ltd. | FLL | Class II | 2021-03-31 |
| K210057 | Blue Nitrile Exam Glove, Powder Free | Real Star Medical Technology Co., Ltd. | LZA | Class I | 2021-03-31 |
| K210058 | Blue Nitrile Exam Glove, Powder Free | Great Harvest Trading Co., Ltd. | LZA | Class I | 2021-03-30 |
| K201734 | AllerBlock Junior | Nasaleze International, Ltd. | NUP | Class II | 2021-03-26 |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | MRZ | Class II | 2021-03-26 |
| K201878 | ST-Z5 | Z-Systems AG | KCT | Class II | 2021-03-25 |
| K202073 | NeedleSmart Professional (NS Pro) | Needlesmart Limited | MTV | Class II | 2021-03-25 |
| K202083 | Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | Shen Wei USA, Inc. | LZA | Class I | 2021-03-25 |
| K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | Shen Wei USA, Inc. | LZA | Class I | 2021-03-24 |
| K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | FRC | Class II | 2021-03-24 |
| K201626 | Safety Subcutaneous Infusion Set | Epic Medical Pte. , Ltd. | FPA | Class II | 2021-03-24 |
| K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 | Shenzhen Juzhong Technology Co., Ltd. | FLL | Class II | 2021-03-22 |
| K202492 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | FMI | Class II | 2021-03-22 |
| K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | Shen Wei USA, Inc. | LZA | Class I | 2021-03-19 |
| K203593 | Patient Examination Gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LZA | Class I | 2021-03-19 |
| K202082 | Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid | Shen Wei USA, Inc. | LZA | Class I | 2021-03-17 |
| K202086 | Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors | Shen Wei USA, Inc. | LZA | Class I | 2021-03-16 |
| K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | LJS | Class II | 2021-03-12 |
| K203666 | Vinyl Examination Gloves(Yellow) | Lutai Medical Technology Co., Ltd. | LYZ | Class I | 2021-03-12 |
| K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | Shenzhen Zhengkang Technology Co., Ltd. | FLL | Class II | 2021-03-12 |
| K201508 | Infrared Thermometer | Dongguan Prestige Sporting Goods Co., Ltd. | FLL | Class II | 2021-03-09 |
| K203618 | Neodent EasyGuide Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2021-03-09 |
| K202591 | Body Infrared Thermometer HT-820D | Dongguan Xintai Instrument Co., Ltd. | FLL | Class II | 2021-03-09 |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | Andon Health Co, Ltd. | FLL | Class II | 2021-03-08 |
| K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove | Shen Wei USA, Inc. | LZA | Class I | 2021-03-05 |
| K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors | Shen Wei USA, Inc. | LZA | Class I | 2021-03-05 |
| K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | MHC | Class II | 2021-03-04 |
| K202879 | EOGas 4 Endo-SteriTest RRBI | Andersen Sterilizers, Inc. | FRC | Class II | 2021-03-03 |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | FRC | Class II | 2021-03-03 |
| K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | 2021-03-02 |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | ONB | Class II | 2021-03-02 |
| K201927 | Getinge GSS610N Series Steam Sterilizer | Maquet GmbH | FLE | Class II | 2021-03-01 |
| K202402 | Nitrile Examination Gloves (Blue, Violet Blue, White) | Jiangsu Tianshuo Medical Products Co., Ltd. | LZA | Class I | 2021-03-01 |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | MRH | Class II | 2021-03-01 |
| K201533 | Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes | Avinent Implant System S.L.U. | KCT | Class II | 2021-03-01 |
| K202111 | Medical infrared forehead thermometer | Hunan Honggao Electronic Technolofy Co., Ltd. | FLL | Class II | 2021-02-26 |
| K203439 | Disposable Vinyl Examination Gloves | Shandong Zhushi Pharmaceutical Group Co., Ltd. | LYZ | Class I | 2021-02-26 |
| K202420 | Infrared Forehead Thermometer | Conmo Electronic Company Limited | FLL | Class II | 2021-02-25 |
| K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set | Simplivia Healthcare , Ltd. | ONB | Class II | 2021-02-25 |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | Hetaida Technology Co., Ltd. | FLL | Class II | 2021-02-25 |
| K201945 | KARL STORZ UDEL Sterilization Trays | Karl Storz Endoscopy America, Inc. | KCT | Class II | 2021-02-25 |
| K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Gmp Medicare Sdn. Bhd. | LZA | Class I | 2021-02-24 |
| K200439 | Velano ExT Extension Set | Velano Vascular | FPA | Class II | 2021-02-23 |
15,723 clearances in the General Hospital panel. Data: openFDA.